May 30, 2025

FDA Approved First AI Tool For 3D Scan Analysis

FDA Approved First AI Tool For 3D Scan Analysis Article Main Image

Recently, Pearl Company – a provider of cutting-edge dental software – received Food and Drug Administration clearance for its AI-powered tool for 3D image analysis, Second Opinion 3D.

This case is the first FDA-approved dental solution to utilize artificial intelligence for diagnosis and treatment. This key step is crucial for the industry and essential for medicine itself.

Let's take a look at that novel tool.

What can it do?

Second Opinion improves dental cone beam computer tomography reviewing by automated detection of key anatomical structures on the scan, including:

  • maxilla and mandible
  • dentition
  • inferior alveolar canal
  • nasal space and airway, etc.

This tool provides clinicians with instant, AI-powered visual data that streamlines diagnostic and treatment processes, enabling them to review CT scans more quickly and accurately than ever before. Second Opinion 3D demonstrates effectiveness in any area of dental practice, from implantology and orthodontics to oral surgery and airway management.

Why is it important?

A few years ago, Pearl received FDA clearance for their AI-powered software for 2D radiologic analysis, and a recently approved 3D solution complements the company's comprehensive toolset for dental diagnostics. This software is a perfect example of the so-called augmented intelligence work approach, where the dentist and AI collaborate to maximize the capabilities of both.

Today, you can join a Second Opinion 3D waitlist to test early access to the tool, see exclusive demos and previews, and receive product release announcements.

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Serhii Zhelieznikov

Editor At Large

After spending few years as a news reporter and editor in medical field, Serhii joined Remedico to make sure that growing Remedico community gets the best and the most important news. Serhii filters hundreds of titles, events and releases daily to bring only what is important.

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